Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field
of cellular metabolism to treat cancer and rare genetic diseases,
today reported business highlights and financial results for the
second quarter ended June 30, 2019.
“In the second quarter we demonstrated our ability to execute
across all areas of our business. Our commercial team continues to
deliver on the AML launch for TIBSOVO® and prepare for our first
potential solid tumor launch on the heels of the positive ClarIDHy
study in cholangiocarcinoma,” said Jackie Fouse, Ph.D., chief
executive officer at Agios. “On the clinical side, we continued to
broaden our IDH program into earlier lines of AML therapy and
expand our PKR programs into new disease areas while enrolling the
PK deficiency pivotal studies. In addition, we completed dose
escalation in our AG-270 Phase 1 trial and are on track to initiate
the next phase of development. The great progress we made during
the quarter keeps us on track to deliver on our remaining 2019
milestones and drive further value across our portfolio.”
SECOND QUARTER 2019 HIGHLIGHTS & RECENT
PROGRESS
- Received approval from the U.S. Food and Drug Administration
(FDA) on May 2, 2019 for single agent TIBSOVO® for the treatment of
adult patients with newly diagnosed acute myeloid leukemia (AML)
with an IDH1 mutation who are ≥ 75 years old or who have
comorbidities that preclude use of intensive induction
chemotherapy.
- Announced the Phase 3 ClarIDHy trial of TIBSOVO® in advanced
previously treated cholangiocarcinoma patients with an IDH1
mutation met its primary endpoint, demonstrating improvement in
progression-free survival by independent radiology review compared
with patients who received placebo.
- Presented updated data from the Phase 1 studies of TIBSOVO® in
frontline AML, both as a monotherapy and in combination with
azacitidine, and the first data from the perioperative study of
TIBSOVO® and vorasidenib in glioma at the 2019 American Society of
Clinical Oncology Annual Meeting. The data presentations can be
found here.
- Began dosing patients in the Phase 1 dose-escalation trial of
AG-636, an inhibitor of the metabolic enzyme dihydroorotate
dehydrogenase (DHODH), in advanced lymphoma.
- Completed the single agent dose-escalation portion of the
ongoing Phase 1 study of AG-270 in methylthioadenosine
phosphorylase (MTAP)-deleted tumors.
- Appointed Orlando Oliveira to the role of senior vice president
and general manager, international. Mr. Oliveira will be
responsible for building and leading the company’s operations
outside of the U.S. in support of the expected launch of TIBSOVO®
in Europe and potentially other select markets.
KEY UPCOMING MILESTONES
The company plans to achieve the following key milestones in the
remainder of 2019:
Oncology:
- Submit a supplemental new drug application to the FDA for
TIBSOVO® for advanced previously treated IDH1 mutant
cholangiocarcinoma by year-end.
- Initiate a registration-enabling Phase 3 study of vorasidenib
in low-grade glioma with an IDH mutation by year-end.
- Initiate expansion phase for the Phase 1 study of AG-270 in
MTAP-deleted tumors, including two combination arms with AG-270 and
taxanes in non-small cell lung cancer and pancreatic ductal
adenocarcinoma, in the third quarter.
Rare Genetic Diseases:
- Complete enrollment in two global pivotal trials for mitapivat
in adults with pyruvate kinase (PK) deficiency by year-end 2019:
- ACTIVATE-T: A single-arm trial of up to 40 regularly transfused
patients
- ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80
patients who do not receive regular transfusions
- Achieve proof-of-concept for mitapivat in thalassemia in the
second half of 2019.
ANTICIPATED 2019 DATA PRESENTATIONS
- Full data from the Phase 3 ClarIDHy study of TIBSOVO® in IDH1
mutant advanced previously treated cholangiocarcinoma have been
submitted for presentation at the European Society for Medical
Oncology Congress taking place in Barcelona, Spain from September
27-October 1, 2019.
- Data from the single agent dose-escalation portion of the
ongoing Phase 1 study of AG-270 in patients with MTAP-deleted
tumors have been submitted to the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics taking
place in Boston from October 26-30, 2019.
- Data from IDH and PKR programs have been submitted for
presentation at the American Society of Hematology Annual Meeting
taking place in Orlando, Fla. from December 7-10, 2019, including
new data from the extension phase of the Phase 2 DRIVE PK study of
mitapivat in adults with PK deficiency and important translational
data from the Phase 1 combination study of TIBSOVO® and azacitidine
in frontline AML.
SECOND QUARTER 2019 FINANCIAL RESULTS
Revenue: Total revenue for the second quarter
of 2019 was $26.2 million, which includes $13.7 million of net
product revenue from U.S. sales of TIBSOVO®, $9.0 million in
collaboration revenue and $2.7 million in royalty revenue from net
global sales of IDHIFA® under our collaboration agreement with
Celgene. This compares to revenue of $40.4 million for the second
quarter of 2018, which included recognition of a $15 million
milestone from Celgene related to Celgene’s filing of an MAA to the
EMA for IDHIFA® and $12.4 million from the signing of the
CStone collaboration.
Cost of Sales: We began U.S. sales of TIBSOVO®
in the third quarter of 2018. Cost of sales were $0.3 million for
the second quarter of 2019.
Research and Development (R&D) Expenses:
R&D expenses were $107.4 million for the second quarter of 2019
compared to $86.7 million for the second quarter of 2018. The
increase in R&D expense was primarily attributable to
vorasidenib Phase 3 low grade glioma trial start-up costs, the
mitapivat pivotal program in PK deficiency and Phase 2 study in
thalassemia, and clinical trial activity related to the ongoing
Phase 1 trials for AG-270 and AG-636.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $32.4 million for the
second quarter of 2019 compared to $26.6 million for the second
quarter of 2018. The increase in SG&A expense was primarily
attributable to costs to support commercialization of TIBSOVO® and
personnel costs related to increased headcount.
Net Loss: Net loss was $109.9 million for the
second quarter of 2019 compared to $68.7 million for the second
quarter of 2018.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of June 30, 2019 were
$624.0 million compared to $805.4 million as of December 31, 2018.
The net decrease of $181.4 million in cash position was primarily
driven by net expenditures to fund operations, including a onetime
cash expense of $19.2 million for bonus payouts during the first
quarter. The company expects that its cash, cash equivalents and
marketable securities as of June 30, 2019, together with
anticipated product and royalty revenue, anticipated interest
income, and anticipated expense reimbursements under our
collaboration and license agreements, but excluding any additional
program-specific milestone payments, will enable the company to
fund its anticipated operating expenses and capital expenditure
requirements through at least the end of 2020.
CONFERENCE CALL INFORMATIONAgios will host a
conference call and live webcast with slides today at 8:00 a.m. ET
to discuss second quarter 2019 financial results and recent
business activities. To participate in the conference call, please
dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international)
and refer to conference ID 9319039. The live webcast can be
accessed under “Events & Presentations” in the Investors
section of the company's website at www.agios.com. The archived
webcast will be available on the company's website beginning
approximately two hours after the event.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat cancer and rare
genetic diseases through scientific leadership in the field of
cellular metabolism and adjacent areas of biology. In addition to
an active research and discovery pipeline across both therapeutic
areas, Agios has two approved oncology precision medicines and
multiple first-in-class investigational therapies in clinical
and/or preclinical development. All Agios programs focus on
genetically identified patient populations, leveraging our
knowledge of metabolism, biology and genomics. For more
information, please visit the company's website at
www.agios.com.
About Agios/Celgene Collaboration IDHIFA®
(enasidenib) and AG-270 are part of our collaboration with Celgene
Corporation. Under the terms of our 2010 collaboration agreement
focused on cancer metabolism, Celgene has worldwide development and
commercialization rights for IDHIFA®. Agios continues to conduct
certain clinical development activities within the IDHIFA®
development program and is eligible to receive reimbursement for
those development activities and up to $80 million in remaining
milestone payments, and royalties on any net sales. Celgene and
Agios are currently co-commercializing IDHIFA® in the U.S. Celgene
will reimburse Agios for costs incurred for its
co-commercialization efforts. AG-270 is part of a 2016 global
research collaboration agreement with Celgene focused on metabolic
immuno-oncology. Celgene has the option to participate in a
worldwide 50/50 cost and profit share with Agios, under which Agios
is eligible for up to $169 million in clinical and regulatory
milestone payments for the program.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding Agios’ plans, strategies and expectations for its and its
collaborator’s preclinical, clinical and commercial advancement of
its drug development programs including TIBSOVO®, IDHIFA®,
vorasidenib, mitapivat, AG-270 and AG-636; the potential benefits
of Agios' product candidates; its key milestones for 2019; its
plans regarding future data presentations; its financial guidance
regarding the period in which it will have capital available to
fund its operations; and the potential benefit of its strategic
plans and focus. The words “anticipate,” “expect,” “hope,”
“milestone,” “plan,” “potential,” “possible,” “strategy,” “will,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from Agios' current
expectations and beliefs. For example, there can be no guarantee
that any product candidate Agios or its collaborators is developing
will successfully commence or complete necessary preclinical and
clinical development phases, or that development of any of Agios'
product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios' business will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other important factors, including: Agios' results of
clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by
regulatory authorities, investigational review boards at clinical
trial sites and publication review bodies; Agios' ability to obtain
and maintain requisite regulatory approvals and to enroll patients
in its planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Agios' ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios'
ability to maintain key collaborations; and general economic and
market conditions. These and other risks are described in greater
detail under the caption "Risk Factors" included in Agios’ public
filings with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Agios expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Condensed Consolidated Balance Sheet
Data(in
thousands)(Unaudited)
|
June 30, 2019 |
|
December 31, 2018 |
Cash, cash equivalents and
marketable securities |
$ |
624,039 |
|
$ |
805,421 |
Accounts receivable, net |
7,147 |
|
5,076 |
Collaboration receivable –
related party |
2,524 |
|
2,462 |
Royalty receivable – related
party |
2,700 |
|
2,234 |
Inventory |
4,659 |
|
869 |
Total assets |
783,870 |
|
858,457 |
Deferred revenue – related
party |
783,870 |
|
92,519 |
Stockholders' equity |
783,870 |
|
687,537 |
Condensed Consolidated Statements of
Operations Data(in thousands, except share and per
share data)(Unaudited)
|
Three Months Ended June
30, |
|
Six Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
13,727 |
|
$ |
- |
|
$ |
22,865 |
|
$ |
- |
Collaboration revenue – related party |
|
8,979 |
|
|
26,401 |
|
|
26,898 |
|
|
33,746 |
Collaboration revenue – other |
|
812 |
|
|
12,440 |
|
|
1,782 |
|
|
12,440 |
Royalty revenue – related party |
|
2,703 |
|
|
1,573 |
|
|
4,903 |
|
|
2,990 |
Total Revenue |
|
26,221 |
|
|
40,414 |
|
|
56,448 |
|
|
49,176 |
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
303 |
|
|
- |
|
|
637 |
|
|
- |
Research and development, net |
|
107,389 |
|
|
86,730 |
|
|
202,974 |
|
|
164,954 |
Selling, general and administrative |
|
32,390 |
|
|
26,633 |
|
|
64,181 |
|
|
51,183 |
Total cost and expenses |
|
140,082 |
|
|
113,363 |
|
|
267,792 |
|
|
216,137 |
Loss from operations |
|
(113,861) |
|
|
(72,949) |
|
|
(211,344) |
|
|
(166,961) |
Interest income |
|
3,990 |
|
|
4,204 |
|
|
8,395 |
|
|
7,391 |
Net loss |
$ |
(109,871) |
|
$ |
(68,745) |
|
$ |
(202,949) |
|
$ |
(159,570) |
Net loss per share – basic and
diluted |
$ |
(1.87) |
|
$ |
(1.19) |
|
$ |
(3.46) |
|
$ |
(2.81) |
Weighted-average number of
common shares used in computing net loss per share – basic and
diluted |
|
58,722,244 |
|
|
57,721,786 |
|
|
58,589,167 |
|
|
56,713,795 |
Investor & Media Contact:Holly Manning,
617-844-6630Associate Director, Investor
RelationsHolly.Manning@agios.com
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